Hepatitis C Virus (HCV) Genotype 3 NS5A Drug Resistance Assay

CPT: 87900; 87902
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Test Details

Synonyms

  • NS5A Resistance Analysis

Use

Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5A inhibitors. Assay should be used for patients with documented HCV genotype 3.

Limitations

This procedure may not be successful when the HCV viral load is <500 IU/mL. This assay requires an HCV genotype of 3.

Methodology

Polymerase chain reaction (PCR) amplification and DNA next generation sequencing (NGS)

Specimen Requirements

Specimen

Plasma (preferred) or serum, frozen

Volume

2 mL

Minimum Volume

1 mL

Container

Ship in plasma preparation tubes (PPT™) or screw-capped polypropylene frozen transport tubes.

Collection

Collect specimen in two PPT™ tubes, gel-barrier tubes, or lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma, transfer specimen to polypropylene screw-capped tubes, and freeze. Specimens drawn into PPT™ tubes need to be centrifuged within six hours and frozen. Ship frozen. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Storage Instructions

Freeze.

Causes for Rejection

PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; specimen received in "pop-top" or "snap-cap" tube

Clinical Information

Special Instructions

Please confirm the patient's HCV genotype 3 prior to submitting sample for testing.

References

Highlights of Prescribing Information. Daklinza™ (daclatasvir) tablets [package insert]. Princeton, NJ; Bristol-Myers Squibb Co; 2015.
McCormack PL. Daclatasvir: A review of its use in adult patients with chronic hepatitis C virus infection. Drugs. 2015 Apr; 75(5):515-524. 25721433

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550603 HCV GT3 NS5A Drug Resist Assay 550598 HCV NS5A Resist Assay PDF 72862-6
550603 HCV GT3 NS5A Drug Resist Assay 550599 HCV NS5A Drug Resist Assay 73655-3
550603 HCV GT3 NS5A Drug Resist Assay 550601 HCV NS5A Resist Assay Interp 49549-9

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